FDA Browser
by
Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
Chemistry
Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart B—Neurological Diagnostic Devices
CFR Sub-Part
Subpart B—Physical Medicine Diagnostic Devices
CFR Sub-Part
IKN
Electromyograph, Diagnostic
2
Product Code
IKT
Electrode, Needle, Diagnostic Electromyograph
2
Product Code
K
17
3815
Allergan Botox Needle Electrode
2
Cleared 510(K)
K
16
1430
Myoject Luer Lock Needle Electrode
2
Cleared 510(K)
K
15
2984
Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes
2
Cleared 510(K)
K
14
3433
Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mm
2
Cleared 510(K)
K
12
0342
EMG RECORDING ELECTRODE ASSEMBLY
2
Cleared 510(K)
K
11
2034
TECA ELITE DISPOSABLE CONCENTRIC NEEDLES
2
Cleared 510(K)
K
11
1131
TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES
2
Cleared 510(K)
K
09
2973
DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE
2
Cleared 510(K)
K
09
3825
AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE
2
Cleared 510(K)
K
09
1410
DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT,
2
Cleared 510(K)
Show All 42 Submissions
LYH
Arthrometer
1
Product Code
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart D—Physical Medicine Prosthetic Devices
CFR Sub-Part
Subpart E—Neurological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—Cardiovascular Therapeutic Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Obstetrical and Gynecological
Review Panel
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 20 December 2024 at 11:05 pm
NE
/
subpart-b—physical-medicine-diagnostic-devices
/
IKT
/
K173815
View Source
Allergan Botox Needle Electrode
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Loading...
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart B—Neurological Diagnostic Devices
Subpart B—Physical Medicine Diagnostic Devices
IKN
Electromyograph, Diagnostic
IKT
Electrode, Needle, Diagnostic Electromyograph
K
17
3815
Allergan Botox Needle Electrode
K
16
1430
Myoject Luer Lock Needle Electrode
K
15
2984
Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, Disposable EP Needle electrodes, Disposable Hypodermic Needle electrodes
K
14
3433
Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mm
K
12
0342
EMG RECORDING ELECTRODE ASSEMBLY
K
11
2034
TECA ELITE DISPOSABLE CONCENTRIC NEEDLES
K
11
1131
TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES
K
09
2973
DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE
K
09
3825
AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE
K
09
1410
DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT,
Show All 42 Submissions
LYH
Arthrometer
Subpart C—Cardiovascular Monitoring Devices
Subpart D—Physical Medicine Prosthetic Devices
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
Subpart F—Cardiovascular Therapeutic Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
NE
/
subpart-b—physical-medicine-diagnostic-devices
/
IKT
/
K173815
View Source
Allergan Botox Needle Electrode
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Loading...